Policy & Compliance

  • February 03, 2025

    Crowell & Moring Lands Former DOJ Assistant Chief For FCPA

    A former assistant chief in the U.S. Department of Justice's Foreign Corrupt Practices Act unit has joined Crowell & Moring LLP as a partner in the firm's white collar and regulatory enforcement group, according to an announcement made Tuesday.

  • February 03, 2025

    5th Circ. Won't Revisit HHS Win On Scope Of ACA

    The Fifth Circuit has declined to conduct an en banc rehearing after an appellate panel upheld a U.S. Department of Health and Human Services rule that said the Affordable Care Act forbids against transgender bias in healthcare, but one judge argued the court got its analysis wrong.

  • February 03, 2025

    Allergan Tells 4th Circ. Medicaid Pricing Suit Rightly Tossed

    Allergan told the Fourth Circuit that a district court judge was right to dismiss a whistleblower's claims that its predecessor overcharged Medicaid by not aggregating discounts, saying the Medicaid Rebate Statute doesn't require it to do so.

  • February 03, 2025

    DC Judge Joins RI In Blocking Trump Funding Freeze

    A D.C. federal judge on Monday temporarily blocked the Trump administration from implementing a freeze on federal spending while a group of nonprofits sue over the move, ruling the pause appears to "suffer from infirmities of a constitutional magnitude."

  • January 31, 2025

    New York Scores Win In Reproductive Rights Labor Law Suit

    A New York federal judge Friday tossed an anti-abortion group's lawsuit challenging a New York state law that bars employers from penalizing workers for making certain reproductive health decisions, saying on the five-year anniversary of the case that the group lacked standing to assert its last remaining claim.

  • January 31, 2025

    Express Scripts Says FTC Tried To Swamp It With Lawsuits

    The Federal Trade Commission was trying to "paint a target on [pharmacy benefit managers'] backs" when it released a report that accused the pharmaceutical middlemen of inflating the cost of drugs, one such PBM told a federal court in defense of its suit against the agency.

  • January 31, 2025

    NY Doctor Charged In La. For Prescribing Abortion Pill Online

    A Louisiana grand jury indicted a New York doctor on Friday, alleging she prescribed abortion drugs online to a Louisiana woman who then provided the pills to her teenage daughter to induce an abortion, a violation of the state's law.

  • January 31, 2025

    Supreme Court Eyes Its 'Next Frontier' In FCC Delegation Case

    A case about broadband subsidies will give the U.S. Supreme Court the chance to revive a long-dormant separation of powers principle that attorneys say could upend regulations in numerous industries and trigger a power shift that would make last term's shake-up of federal agency authority pale in comparison. And a majority of the court already appears to support its resurrection.

  • January 31, 2025

    After High Court, SuperValu's $123M FCA Case Heads To Trial

    SuperValu is bound for trial in February over whistleblower claims that it billed the government higher-than-customary prices for millions of prescriptions, marking an important test of a recent U.S. Supreme Court ruling that revived the case and redefined the standard of proof under the False Claims Act.

  • January 31, 2025

    Trump Funding Freeze Blocked As Court Doubts Reversal

    A Rhode Island federal judge on Friday issued a temporary restraining order barring the Trump administration from freezing spending on federal grant and aid programs, calling the move illegal and saying the issue was not mooted by a White House memo claiming the directive had been rescinded.

  • January 31, 2025

    JAMS Adds AI-Focused Litigation Vet To Arbitration Team

    The alternative dispute resolution service JAMS has expanded its arbitration and mediation team with the addition of an attorney with over three decades of experience spanning complex commercial litigation, independent arbitration and leadership positions at the American Bar Association.

  • January 31, 2025

    RFK Jr. Says He'll Give Stake In Merck Vaccine Case To Son

    Robert F. Kennedy Jr., President Donald Trump's pick for the nation's top healthcare position, said Friday that he would hand his financial stake in personal injury litigation against vaccine maker Merck over to an adult son.

  • January 30, 2025

    Plaintiffs, Pfizer Spar Over Where To Join Depo-Provera Suits

    Consumers who claim Pfizer Inc. failed to adequately warn patients and doctors about the risk of brain tumors associated with the hormonal contraceptive drug Depo-Provera urged the U.S. Judicial Panel on Multidistrict Litigation on Thursday to consolidate their cases but sparred over whether to move them to California or New York.

  • January 30, 2025

    Ga. Businesses 'Over The Moon' With Tort Reform Proposals

    Georgia Gov. Brian Kemp unveiled a long-awaited tort reform package Thursday that, if passed, would limit businesses' premises liability, limit plaintiffs' attorneys' rhetoric around damages and require increased disclosures for third-party litigation funding, among a slew of other proposals.

  • January 30, 2025

    DOJ Calls UnitedHealth Dismissal Bid A Discovery 'End Run'

    The U.S. Department of Justice assailed UnitedHealth Group on Wednesday for "masquerading" a "premature" discovery bid as a motion to dismiss the government's Maryland federal court lawsuit challenging the $3.3 billion purchase of home health and hospice giant Amedisys Inc.

  • January 30, 2025

    RFK Blasts Industry 'Puppets' Amid HHS Nomination Fight

    Robert F. Kennedy Jr. said Thursday that federal scientific panels are rife with conflicts of interest that have turned them into "sock puppets" for industry, as he faced a second day of intense questioning on Capitol Hill and sought support for his nomination as secretary of health and human services.

  • January 29, 2025

    Albertsons Must Face County's Opioid Nuisance Claims

    Albertsons Cos. Inc. can't escape a Texas county's public nuisance claims stemming from opioid sales at the grocery giant's in-store pharmacies, an Ohio federal judge ruled Tuesday, saying there's a "common law duty of care" for pharmacies not to expose the county to a "reasonably foreseeable" risk of harm.

  • January 29, 2025

    Lab Co-Owner Gets 9 Years For $369M COVID Testing Scheme

    The co-owner of a California medical laboratory was sentenced to nine years in prison after being accused of conspiring to defraud Medicare and private insurers out of $369 million by submitting claims for medically unnecessary tests during the COVID-19 pandemic emergency.

  • January 29, 2025

    White House Rescinds Trump's Spending Freeze

    The White House on Wednesday rescinded a directive freezing federal funding, saying it wants to end litigation and confusion, but said the move will not end a review of spending to ensure compliance with a series of executive orders by the president.

  • January 29, 2025

    RFK Jr. Disputes Anti-Vax Label In HHS Confirmation Hearing

    Robert F. Kennedy Jr. attempted Wednesday morning to convince Republican and Democratic lawmakers that he is not anti-vaccine, despite many of his past comments to the contrary, as he hopes to convince them to confirm his appointment as head of the U.S. Department of Health and Human Services.

  • January 28, 2025

    Trump Targets Gender-Affirming Care For Minors In New Order

    President Donald Trump ordered federal agencies late Tuesday to take steps to halt gender-affirming care for minors, including by cutting off Medicaid and military health coverage for what he called a "stain on our nation's history."

  • January 28, 2025

    Minn. AG Settles Novo Nordisk Insulin Claims With Price Cap

    Minnesota's attorney general has reached a settlement resolving a long-running lawsuit accusing Novo Nordisk of inflating insulin prices, with the company agreeing to a $35 per month cap on out-of-pocket costs for state residents.

  • January 28, 2025

    Wash. Judge Asks If Dr.'s Ivermectin Discipline Was Political

    A Washington appellate judge asked Tuesday if a doctor who was disciplined by a medical board for prescribing the controversial drug ivermectin to COVID-19 patients was targeted for his political views, while another judge asked if "all lies" about medical information are protected speech.

  • January 28, 2025

    Questions To Watch For In RFK Jr.'s Confirmation Hearing

    Robert F. Kennedy Jr. is set to appear on Capitol Hill as he tries to secure the top position at the U.S. Department of Health and Human Services. Here are some of the questions healthcare lawyers and others want to see addressed about his "Make America Healthy Again" pledge.

  • January 28, 2025

    Feds Say Health System Can't Ditch Fraud Suit Over Surgeries

    The federal government and state of Washington urged a judge on Monday to allow their suit against a hospital operator to move forward, saying they have provided more than enough detail to support allegations that the health system knew a doctor was performing unnecessary surgeries.

Expert Analysis

  • Strategies To Defend Against Healthcare Nuclear Verdicts

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    The healthcare industry is increasingly the target of megaclaims, particularly those alleging medical malpractice, but attorneys representing providers can use a few tools to push back on flimsy litigation and reduce the likelihood of a nuclear verdict, says LaMar Jost at Wheeler Trigg.

  • What Drug Cos. Must Know About NY Price Transparency Law

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    Drug manufacturers must understand the contours of New York's recently implemented law requiring self-reporting of drug price increases, as well as best practices for compliance and challenges against similar laws in other states, say Elizabeth Bierut and Angie Garcia at Friedman Kaplan.

  • Whistleblowers Must Note 5 Key Differences Of DOJ Program

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    The U.S. Department of Justice’s recently unveiled whistleblower awards program diverges in key ways from similar programs at other agencies, and individuals must weigh these differences and look first to programs with stronger, proven protections before blowing the whistle, say Stephen Kohn and Geoff Schweller at Kohn Kohn.

  • The Licensure Landscape For Psychedelics Manufacturers

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    As the need for bulk manufacturing of psychedelic substances grows, organizations aiming to support clinical trials or become commercial suppliers must navigate a rigorous and multifaceted journey to obtaining a license from the U.S. Drug Enforcement Administration, say Kimberly Chew at Husch Blackwell and Jaime Dwight at Promega Corp.

  • OSHA Workplace Violence Citation Highlights Mitigation Steps

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    The Occupational Safety and Health Administration's recent citation against behavioral health company Circles of Care sheds light on the enforcement risks companies may face for failing to prevent workplace violence, and is a reminder of the concrete steps that can help improve workplace safety, say attorneys at Benesch.

  • When Banks Unknowingly Become HIPAA Biz Associates

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    There appears to be significant confusion regarding the application of the Health Insurance Portability and Accountability Act to financial institutions when serving healthcare-related clients, so these institutions should consider undertaking several steps as a starting point in the effort to achieve compliance, say attorneys at Vorys.

  • The Regulatory Headwinds Facing Lab-Developed Tests

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    Though the U.S. Food and Drug Administration's final rule regarding regulation of laboratory-developed tests outlines a four-year plan for ending enforcement discretion, and though this rule is currently being challenged in courts, manufacturers should heed compliance opportunities immediately as enforcement actions are already on the horizon, say attorneys at Kirkland & Ellis.

  • 3 High Court Rulings May Shape Health Org. Litigation Tactics

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    Three separate decisions from the U.S. Supreme Court's most recent term — Loper Bright, Corner Post and Jarkesy — will likely strengthen healthcare organizations' ability to affirmatively sue executive agencies to challenge regulations governing operations and enforcement actions, say attorneys at McDermott.

  • A New Way Forward For COVID Vaccine Lawsuit Immunity

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    As Public Readiness and Emergency Preparedness Act protections for COVID-19 vaccines wane, adding those vaccines to coverage by the National Vaccine Injury Compensation Program would bolster defenses for administrators and manufacturers while also providing stronger remedies for those injured by vaccines, says Altom Maglio at MCT Law.

  • Why DOJ's Whistleblower Program May Have Limited Impact

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    The U.S. Department of Justice’s new whistleblower pilot program aims to incentivize individuals to report corporate misconduct, but the program's effectiveness may be undercut by its differences from other federal agencies’ whistleblower programs and its interplay with other DOJ policies, say attorneys at Milbank.

  • How Cos. With Chinese Suppliers Should Prep For Biotech Bill

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    A proposed bill to prohibit government-affiliated life sciences companies from contracting with Chinese biotech companies of concern may necessitate switching to other sources for research and supplies, meaning they should begin evaluating supply chains now due to the long lead times of drug development, say John O'Loughlin and Christina Carone at Weil Gotshal.

  • FTC's Drug Middlemen Probe Highlights Ongoing Scrutiny

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    The Federal Trade Commission's interim staff report on its inquiry into pharmacy benefit managers suggests that the industry will remain under an enforcement microscope for the foreseeable future due to concerns about how PBMs affect drug costs and accessibility, say attorneys at Arnold & Porter.

  • What Cos. Should Note In DOJ's New Whistleblower Pilot

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    After the U.S. Department of Justice unveiled a new whistleblower pilot program last week — continuing its efforts to incentivize individual reporting of misconduct — companies should review the eligibility criteria, update their compliance programs and consider the risks and benefits of making their own self-disclosures, say attorneys at Skadden.